Build a strategy for the digital transformation of Regulatory Affairs
The importance of the RA organization necessitates a strategic approach to digital transformation. This digital strategy should systematically adopt new technologies while improving efficiency and transparency in existing technologies by adding solid data foundations and business intelligence.
- A Digital Transformation Strategy is key to your success in a data-driven submission organization where tools and data support business decisions and collaboration with affiliates and with other business units.
- In this session NNIT RA Advisory will share key insights to build the digital strategy and set the goals for your organization, ensuring a solid foundation to take ownership of the digital transformation and reap the benefits of this transition in RA.
Dr. Niels Buch Leander is Advisory Director and Global Head of Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 12 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and IDMP and hence extensive experience with regulatory data standards and their implementation. He advises global pharmaceutical companies on their business architecture and information architecture.
We understand the challenges that pharmaceutical companies are facing. Your challenges.
In a heavily regulated industry like life sciences, insight and expertise are prerequisites for developing the business through technology and IT. This applies whether your goal is to optimize business processes, reduce costs, or shorten the road from idea to market.
The digital technology holds enormous potential for pharmaceutical companies. Among other things, it can speed up your Quality Management while simultaneously making it more resilient through automation.
With a unified platform, you can set your clinical data free, allowing you to use it more intelligently. At the same time, you can support your development and production of medicine and medical equipment with Cloud solutions customized to your unique industry needs.
At NNIT, we have more than 20 years of experience as an IT service provider for the pharmaceutical industry. Our work is firmly anchored in well-tested software and technology standards, which we adapt to your concrete business objectives and requirements. With extensive experience and specific competences, our experts are always at your service, no matter where in the world you need them.
All our solutions are based on industry best practice. They can be integrated with your existing IT landscape and are fully compliant with the demands of the FDA, EMA and other regulators.